Senior Staff Microbiologist - Cork, Carrigtwohill IDA Business & Technology Park Springhill

Work Flexibility: Onsite

Who we want:

• Meticulous documenters. Detail-oriented people who enjoy maintaining meticulous documentation of reports, metrics, proposals, and presentations.
• Self-directed initiators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.

What you will do: 

• Environmental monitoring of cleanrooms for viable air, viable surface and particulate in line with ISO 14644 standards. 
• Monitoring of utilities including all grades of water, and where necessary, compressed air. 
• Co-ordination of samples for bioburden and endotoxin testing. 
• Ordering consumables (media etc) and general stock for day-to-day running of laboratory. 
• Applying cGLP to all laboratory activities including stock control. 
• Performing sampling for validations and re-qualifications as required. Review of validation files for compliance. 
• Strong interactions, maintenance and support of sterility suppliers. 
• Interpreting sampling and monitoring data, applies statistical and analysis techniques, to determine control and trending. 
• Leads NC and CAPA generation and resolution within the Microbiology group and across related business units. Strong competency in troubleshooting, correction of NC and root cause analysis. 
• Performs sterility release review, interpreting data and trends. 
• Continually identifies opportunity for stabilization of trends, statistical control of processes to allow cost saving. 
• Mentors and trains team and cross functional groups as required (induction, GMP etc) 
• Subject matter expert to local procedures, contribute to the development, maintenance and improvements of the policies and procedures to align to best practices, benchmarking against industry leads and regulatory requirements.
• Coach, mentor and train other functions in area of sterility and monitoring. 

What are we looking for: 

• Bachelor’s degree/ Master of Microbiology or equivalent 
• Minimum of 6 years in Quality/Regulatory Affairs environment or  6 years Microbiology related experience. 
• Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.) required. 
• Must possess effective communication, project management and influencing skills as well as have the ability to manage multiple tasks simultaneously. 
• Strong interpersonal skills. 
• Strong written and oral communication and negotiations skills. 
• Strong in critical thinking and "outside the box" thinking. 
• Highly developed problem-solving skills. 
• Strong analytical skills. 
• Demonstrated ability to successfully manage and complete projects in a matrix organization. 
• Demonstrated ability to work independently. 
• Experience in working in a compliance risk situation. 
• High proficiency in statistical techniques, data review and analysis. 

Travel Percentage: None